Clinical Trials Register

Summary
EudraCT Number:	2019-004118-33
Sponsor's Protocol Code Number:	PATCH_Trauma
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-06-16
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2019-004118-33

A.3

Full title of the trial

A multi-centre randomised, double-blind, placebo-controlled trial of pre-hospital treatment with tranexamic acid for severely injured
patients at risk of acute traumatic coagulopathy.

Eine multizentrische, randomisierte Placebo-kontrollierte und verblindete Studie zur prähospitalen Antifibrinolytikagabe bei traumatischer Koagulopathie und Blutung (PATCH)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Tranexamic Acid use in patients that suffering severe injury that is associated with excessive bleeding and coagulation disorder

Verwendung von Tranexamsäure bei schwerverletzten Patienten mit übermäßiger Blutung und Gerinnungsstörung

A.3.2

Name or abbreviated title of the trial where available

PATCH

A.4.1

Sponsor's protocol code number

PATCH_Trauma

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02187120

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1169-6738

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Universität Witten/Herdecke
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Deutsche Forschungsgemeinschaft (DFG)
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Institut für Forschung in der Operativen Medizin
B.5.2	Functional name of contact point	IFOM
B.5.3	Address:
B.5.3.1	Street Address	Ostmerheimerstr. 200, Haus 38
B.5.3.2	Town/ city	Köln
B.5.3.3	Post code	51109
B.5.3.4	Country	Germany
B.5.4	Telephone number	004902219895718
B.5.5	Fax number	0049023029264444
B.5.6	E-mail	patch@uni-wh.de

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Cyklokapron Injektionslösung 1000mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Pharma PFE GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Tranexamic acid
D.3.2	Product code	TXA
D.3.4	Pharmaceutical form	Infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent) Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Tranexamic Acid
D.3.9.1	CAS number	1197-18-8
D.3.9.4	EV Substance Code	SUB11214MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	synthetic aminoacid derivative

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Injection
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Trauma patients with risk for acute traumatic Coagulopathy and Hemorrhage

Traumapatienten mit einem Risiko für akute traumatische Koagulopathie und Blutungen

E.1.1.1

Medical condition in easily understood language

Fibrinolysis and bleeding resulting from lifethreatening wounds and injuries

Fibrinolyse und Blutungen als Konsequenz lebensbedrohlicher Wunden und Verletzungen

E.1.1.2

Therapeutic area

Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10044528
E.1.2	Term	Traumatic injury
E.1.2	System Organ Class	100000004863

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine the effect of early administration of TXA, compared to placebo, on mortality and favourable outcomes (moderate disability or good recovery) at six
months in severely injured adults at risk of ATC who are treated in advanced trauma systems

Ermittlung der Wirkung einer frühestmöglichen Verabreichung von TXA verglichen mit Placebo auf die Mortalität und das 6-Monats-Outcome von schwerverletzten Traumapatienten mit Risiko für eine akute traumatische Koagulopathie, die in fortgeschrittenen Traumasystemen behandelt werden

E.2.2

Secondary objectives of the trial

1) To determine the effect of early administration of TXA, compared to placebo, on coagulation and fibrinolysis, and on clinical outcomes that are mediated
through other putative inflammatory, immune, and neurological effects of plasmin.
(2) To determine whether early administration of TXA, compared to placebo, is associated with excessive vascular occlusive events, especially among potentially higher risk patients (eg >50 years old).

(1) Es soll der Effekt einer frühen Verabreichung von TXA im Vergleich zum Placebo auf die Gerinnung und die Fibrinolyse sowie auf das klinische Outcome bestimmt werden, die durch andere mutmaßliche entzündliche, immunologische und neurologische Effekte von Plasmin vermittelt werden.
(2) Es soll ermittelt werden, ob eine frühzeitige Verabreichung von TXA verglichen zum Placebo mit übermäßigen vaskulären okklusiven Ereignissen verbunden ist, insbesondere bei potenziell risikoreichen Patienten (z.B. Alter >50 Jahre).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Adult patients (age ≥18 years);
2. Injured through any mechanism;
3. COAST score ≥3;
4. First dose of study drug can be administered within three hours of injury; and
5. Patients to be transported to a participating trauma centre.

1. Erwachsene Traumapatienten (Alter ≥18 Jahre)
2. Verletzung infolge eines beliebigen Unfallmechanismus
3. Coagulopathy of severe trauma (COAST) score ≥3 Punkte
4. Die erste Dosis des Studienmedikaments kann innerhalb von 3 Stunden nach Trauma verabreicht werden.
5. Patienten, die zu einem teilnehmenden Traumazentrum transportiert werden

E.4

Principal exclusion criteria

1. Suspected pregnancy
2. Nursing home residents

1. Vermutete Schwangerschaft
2. Bewohner von Pflegeheimen

E.5 End points

E.5.1

Primary end point(s)

The proportion of patients with a favourable outcome at six months (moderate disability to good recovery, GOSE scores 5-8) compared to those who have died (GOSE 1), or have severe disability (GOSE 2-4).

Der Anteil an Patienten 6 Monate nach Trauma mit einem günstigen Outcome (gute Genesung bis mittlere Behinderung, GOSE Score 5-8) verglichen zu jenen, die versterben (GOSE Score 1) oder schwer beeinträchtigt sind (GOSE Score 2-4).

E.5.1.1

Timepoint(s) of evaluation of this end point

at six months after enrollment

6 Monate nach Einschluss

E.5.2

Secondary end point(s)

1) Units of blood products used (packed red blood cells, fresh frozen plasma, platelets, prothrombin complex concentrate, Factor VIIa, cryoprecipitate) in the first 24 hours
2) Blood lactate concentration at patient arrival to hospital
3) Coagulation profile (INR, APTT, fibrinogen, platelet count) at
a. hospital arrival
b. end of treatment with study drug (i.e. immediately after administering the second dose of the study drug by 8 hour infusion)
c. 24 hours after the first dose of study drug (i.e. 24 hours from the pre-hospital bolus dose)
4) Vascular occlusive events (acute myocardial infarction (AMI), stroke, DVT, PE) up until 28 days or hospital discharge whichever occurs first
5) Ventilator-free days in first 28 days
6) Mortality
a. 24 hours
b. 28 days
c. 6 months
7) Proportion of deaths due to
a. Bleeding
b. Vascular occlusion (PE, stroke or AMI)
c. Multi-organ failure
d. Head injury
8) Cumulative incidence of sepsis up until 28 days or hospital discharge whichever occurs first
9) Quality of life (WHODAS 2.0 and EQ5D) at 6 months.

E.5.2.1

Timepoint(s) of evaluation of this end point

1) Units of blood products used in the first 24 hours
2) Blood lactate concentration at patient arrival to hospital
3) Coagulation profile at
a. hospital arrival
b. end of treatment with study drug
c. 24 hours after the first dose of study drug
4) Vascular occlusive events up until 28
days or hospital discharge
5) Ventilator-free days in first 28 days
6) Mortality
a. 24 hours
b. 28 days
c. 6 months
7) Proportion of deaths up until 28 days or hospital discharge whichever occurs first
8) Cumulative incidence of sepsis up until 28 days or hospital discharge whichever occurs first
9) Quality of life at 6 months.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

New Zealand

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

300

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

300

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-06-16.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Trauma patients who are treated by emergency doctors of a rescue helicopter from the participating centers (first IMP dose administered at the scene of the accident)

Traumapatienten, die von Notärzten eines Rettungshubschraubers der teilnehmenden Zentren behandelt werden (erste IMP-Verabreichung vor Ort am Unfallort)

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

300

F.4.2

For a multinational trial

F.4.2.1

In the EEA

300

F.4.2.2

In the whole clinical trial

1316

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

none

keine

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-11-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-05-27

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-03-25

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